Cleared Traditional

K201400 - npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201400 · Aatru Medical, LLC · General & Plastic Surgery device
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Aug 2021
Decision
452d
Days
Class 2
Risk

K201400 is an FDA 510(k) clearance for the npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™. Classified as Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical (product code QPX), Class II - Special Controls.

Submitted by Aatru Medical, LLC (Cleveland, US). The FDA issued a Cleared decision on August 23, 2021 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4683 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K201400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2020
Decision Date August 23, 2021
Days to Decision 452 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 114d · This submission: 452d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPX Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4683
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.